Healing Track Clinical Trial
ConditionChronic Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This is a randomized clinical trial to evaluate a digital pain reprocessing therapy (PRT) intervention for chronic back pain (CBP).
The purpose of this research is to test whether a new digital treatment for chronic pain works as well as traditional treatments for chronic back pain (CBP). Some people with CBP experienced side effects from other treatments, or previous treatments did not relieve pain, so this research aims to see if a digital therapy is a better option for CBP.
This study will assess changes in pain intensity from PRT intervention compared to a standard of care (SOC) control group in adults with CBP. SOC is defined as a comprehensive clinical care plan, including a consultation with physiatrist and prescribed interventions, which will capture a comparison representative of all potential interventions that are recommended for an individual.
The research team plans to enroll 180 participants who will be randomized into one of three groups.
Eligibility criteria
Qualifiers
Aged 21 to 70
Chronic Back Pain- CBP will be defined according to the criteria established by a recent NIH task force
Pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months.
Patients must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPISF) (on the item measuring average pain over the last week).
Disqualifiers
Back pain associated with compensation or litigation issues as determined by self-report within the past year
Leg pain is greater than back pain, as this suggests neuropathic pain, which may be less responsive to psychotherapy
Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function
Self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder
Trial design
Treatments tested in this trial
- Self-Guided Program (Tier 1)
- Coach Assisted Program (Tier 3)
- Standard of Care (SOC)
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
Healing Track
Collaborator
Source ClinicalTrials.gov